Stents are well known to those skilled in the biomedical arts. In particular, stents are commonly used in cardiovascular applications. Stents have gained increasing acceptance, particularly when used in conjunction with minimally invasive procedures such as angioplasty. Blockages of the coronary arteries may result from various causes, including plaque build-up, and stenosed or thrombosed vessel regions. The vessel regions thus partially occluded can cause angina and, when totally occluded, myocardial infarction, and even death. Minimally invasive procedures such as balloon angioplasty have been used to dilate such blocked vessel regions, thereby at least partially restoring patent vessel lumens.
In a significant percentage of cases, a stenosed, then dilated vessel region may narrow after treatment over a period ranging from days to months. This re-narrowing or restenosis, limits the efficacy of the angioplasty procedures, may require further angioplasty, or can lead to myocardial infarction and even death.
Cerebral blockages are typically caused by a thrombus. The thrombus can form or lodge in a cerebral artery, preventing brain regions downstream from receiving perfusing blood flow. The loss of oxygen can rapidly cause brain death in the affected brain regions if the blockage is not soon treated. The cerebral arteries are generally smaller and more tortuous than the corresponding coronary arteries. The required timing and difficult vessel characteristics make reaching and treating the thrombus to prevent brain cell death a most difficult task. The narrow cerebral vessels make placing stents within the brain very difficult using current stents and stent delivery systems. Microcatheters are currently used to infuse drugs into cerebral blood vessels. The microcatheters are typically not greater than about 4 Fr. (1⅓ min.) in outer diameter, currently being generally unsuitable for delivery of cerebral stents.
Stents have been extensively utilized in an attempt to prevent or limit restenosis. Stents are typically tubular devices delivered to the stenosed and dilated site. The stents can be expanded into place against the treated region walls, hopefully preventing restenosis and further narrowing at the stented location. Stents are often formed of metal, commonly stainless steel or Nitinol. The stents can be open walled structures formed from lattice-like cages, spiral wire structures, braided structures, and helically wound and counter-wound structures. Stents can be self-expanding, designed to expand radially when distally advanced from a restraining delivery catheter. Stents can also be balloon-expandable. Balloon-expandable stents can be positioned and then expanded from within using a stent delivery balloon and/or an angioplasty balloon.
A typical stent delivery device includes a stent constrained within an outer delivery sheath extending over the length of the stent. When the device is advanced to the target site, the outer sheath is proximally retracted and/or the stent is distally advanced from within the sheath to the target site. The delivery sheaths may work as intended, but do add bulk to the distal end of the delivery device. In particular, the delivery sheath adds at least one additional layer surrounding the stent. The delivery sheaths are generally cylindrical in nature and extend over the entire length of the stent. The stent can act to reinforce the outer sheath. The delivery sheath and enclosed stent thus act to form a rather rigid composite structure that is not as able to bend and traverse the tortuous vessel regions often found in the human body. The composite structure is thus not as flexible as either the stent or sheath alone would be in traversing these passages.
The added bulk and profile or cross-sectional area of the delivery device can thus act to restrict the use of such stents to larger vessels. In particular, this may leave smaller vessels unreachable and untreatable. Sites requiring treatment disposed on the distal side of a tortuous curve may also be unreachable and untreatable.
In use, some currently available stents and delivery systems also have another limitation. For self-expanding stents, stent placement is often imprecise. The placed or final stent length is related to the final stent diameter that is related to the vessel diameter. Within a vessel, the diameter is not always precisely known, and can vary over the region to be stented. It may be nearly impossible to predict the final stent length before the stent is fully expanded in the vessel.
The difficulty in accurate stent placement can become an issue in stenting a vessel ostium. It is often desirable to place a stent precisely at the ostium of a vessel, especially in coronary and renal vessels. If the stent is positioned too proximal, the stent extends into the trunk line, and can cause flow disturbance. If the stent is positioned too distal, the disease at the ostium is not treated. Self-expanding stent delivery systems typically deploy the stent from distal to proximal, with the distal stent end being advanced distal-most. In particular, a self-expanding stent may be advanced while disposed within a delivery sheath. When the sheath distal end is in position, the sheath can be refracted, allowing the accurately placed stent distal end to expand first. The proximal end of the stent can vary depending on the vessel diameter. In order to accurately place the stent proximal end, the treating physician thus needs to guess at the position to start stent deployment based on the assumed final stent length, so that the proximal end of the stent ends up at the precise ostial location desired.
What would be desirable are devices and methods for delivering stems to target vessel regions that do not require the added bulk of an external restraint or capture sleeve over the stent. Applicants believe that devices and methods not absolutely requiring a delivery sheath over the stent would allow smaller, more tortuous, and more distal vessels to be effectively treated.